IPM study

Background:

The IPM 100.1 study was conducted at Africa University – Clinical Research Centre (AUCRC) in collaboration with International Partnership for Microbicide (IPM) from 2010 to 2012. The main aim of the study was to estimate HIV incidence among sexually active, adult women in Mutare, Zimbabwe. The Clinical Research Center established a formalized community advisory mechanism in the form of a Community Advisory Board (CAB) that provided community input in study procedures and assisted the researchers with community education and mobilization. Women who expressed an interest in study participation were invited to visit the research center for screening and possible enrollment. Participants provided written informed consent prior to any study-related procedures.  Screened participants who were considered eligible were enrolled into the cross-sectional study.  Screened participants included in the cross-sectional study who were HIV-negative were considered for enrollment into the prospective, observational cohort study which involved quarterly visits over a 12-month follow-up period (visits were scheduled at 3, 6, 9 and 12 months).  Three hundred of the screened participants who were HIV seronegative and met all the inclusion and none of the exclusion criteria were enrolled into the observational cohort study and observed for HIV seroconversion at each quarterly follow-up visit.      

Objectives: The primary objective of the study was:

• To estimate human immunodeficiency virus (HIV) incidence among sexually active, adult females, in preparation for HIV microbicide efficacy trials.
• To detect acute HIV infections in study participants.

Some major achievements of the study

• At the end of the study, 824 women were included in the cross-sectional study. Of these, 300 were enrolled into the cohort study of whom 278 (92.7%) women completed all scheduled study visits. 
• AUCRC in 2011 received Best Financial Management Practices Award and Best Community Engagement Award from the sponsor IPM.
• Successful retention of study participants at 94.3%
• 91% of Case Report Forms deemed clean on arrival
• A 3% Quality Control (QC) rate per 100 records throughout the duration of the study.

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